The first knee prosthesis to go through beyond compliance: A new standard for the safe introduction of orthopaedic implants.

The Surgeon : Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland
N G PatelA D Toms

Abstract

Beyond Compliance (BC) was introduced in 2012 to improve the monitoring and regulation of new medical devices and techniques, ensuring patient safety whilst promoting innovation through an evidence based appraisal of devices during their introduction. This study reports the 2 year outcomes of the first Total Knee Replacement (TKR) implant to be assessed through the BC process. 100 consecutive patients undergoing primary knee arthroplasty were enrolled. All patients received a single radius cruciate retaining TKA (Unity, Corin), and the patella was resurfaced in all cases. Patients were followed up at 6 weeks, 3, 6, 12 and 24 months post operatively. Pre-and post-operative range of movement (ROM) as well as outcome scores including OKS, KOOS, EQ5D index and EQ5D VAS were recorded. 100 patients with a mean age 73.6 (SD = 8.7) were included. 2 patients died during the follow-up period due to unrelated reasons. Overall satisfaction rates were 96%. Complications included ongoing pain (5 patients), and a periprosthetic fracture (1 patient) nine months post-surgery (traumatic). No knees were revised during the follow-up period. Significant improvements were observed in all outcomes measures (OKS, KOOS, EQ5D, and EQ5D VAS). The mean ad...Continue Reading

Citations

Aug 3, 2021·The Bone & Joint Journal·Joanna CravenDaniel C Perry
Aug 11, 2021·Telemedicine Journal and E-health : the Official Journal of the American Telemedicine Association·Eoin FaheyMay S Cleary

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